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510(k) K112562

BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER by Kimberly-Clark — Product Code OYI

K112562 is an FDA 510(k) premarket notification submitted by Kimberly-Clark for the device "BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER". The FDA issued a decision of Substantially Equivalent on December 15, 2011. The device falls under product code OYI (Non-Bronchoscopic Bronchoalveolar Lavage Catheter), a Class I device regulated under 21 CFR 868.6810. Kimberly-Clark has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2011
Date Received
September 26, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Non-Bronchoscopic Bronchoalveolar Lavage Catheter
Device Class
Class I
Regulation Number
868.6810
Review Panel
AN
Submission Type

To perform non-bronchoscopic bronchoalveolar lavage (bal) in adult patients undergoing mechanical ventilation.

Other clearances by Kimberly-Clark

  • K140963 — KIMGUARD SMART-FOLD STERILIZATION WRAP (November 10, 2014)
  • K141294 — U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS (August 25, 2014)
  • K131879 — KC 300 SURGICAL MASK (December 20, 2013)
  • K131841 — KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE (November 7, 2013)
  • K131254 — KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE (August 20, 2013)
  • K120985 — KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING (December 19, 2012)
  • K112805 — KIMGUARD ONE-STEP STERILIZATION WRAP (June 22, 2012)
  • K113340 — KIMBERLY-CLARK CHILD'S FACEMASK (May 4, 2012)
  • K113423 — KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE (March 9, 2012)
  • K112300 — KIMGUARD SMART-FOLD* STERILIZATION WRAP (January 19, 2012)

FDA data resources